Boehringer Mannheim Corp.: FDA filings under this applicant name
FDA lists 340 510(k) clearances under the applicant name “Boehringer Mannheim Corp.” (first 1976, latest 1999), plus 1 PMA decision, across 146 product codes in 8 review panels. Median 510(k) review time under this name: 49 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Roche Diagnostics, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 24 | 24 |
| CGA | Glucose Oxidase, Glucose | 17 | 17 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 17 | 17 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 16 | 16 |
| LFR | Glucose Dehydrogenase, Glucose | 9 | 9 |
| JIX | Calibrator, Multi-Analyte Mixture | 8 | 8 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 7 | 7 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 6 | 6 |
| KQO | Automated Urinalysis System | 6 | 6 |
| MMI | Immunoassay Method, Troponin Subunit | 6 | 6 |
Plus 136 more product codes.
Review panels
- Clinical Chemistry (252)
- Immunology (40)
- Clinical Toxicology (25)
- Hematology (16)
- Microbiology (3)
- General and Plastic Surgery (2)
- Anesthesiology (1)
- Orthopedic (1)
Most recent Boehringer Mannheim Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984326 | ELECYS IGE ASSAY | JHR | 1999-02-08 | 67 |
| K983047 | ACCU-CHEK HQ SYSTEM | LFR | 1999-02-05 | 157 |
| K984419 | ELECSYS IGE CALCHECK | JJY | 1999-02-02 | 54 |
| K984425 | MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR | JIX | 1999-01-20 | 40 |
| K984372 | ELECSYS CALCHECK TROPONIN T | JJY | 1998-12-14 | 7 |
| K984105 | ELECSYS TROPONIN T STAT TEST | MMI | 1998-12-08 | 21 |
| K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 | CEO | 1998-12-01 | 56 |
| K983469 | PRECISET SERUM PROTEINS CALIBRATOR | JIX | 1998-11-25 | 55 |
| K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | DGC | 1998-11-12 | 62 |
| K983510 | CHEMSTRIP 101 URINE ANALYZER | KQO | 1998-10-27 | 20 |
330 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P820073 | PMA | MICUR-MIC SYSTEMS | 1983-06-29 |
Recalls
openFDA lists no recalls under a recalling firm named Boehringer Mannheim Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Boehringer Mannheim Corp. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Boehringer Laboratories (44 510(k)s)
- Boehringer Mannheim Italia Spa (3 510(k)s)
- Boehringer Ingelheim Pharmaceuticals, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Boehringer Mannheim Corp.?
FDA lists 340 510(k) clearances under the applicant name “Boehringer Mannheim Corp.” (first 1976, latest 1999), plus 1 PMA decision, across 146 product codes in 8 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Boehringer Mannheim Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Boehringer Mannheim Corp. is 49 days.
Which FDA product codes appear under Boehringer Mannheim Corp.?
The most frequent FDA product codes under this applicant name are JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 24); CGA (Glucose Oxidase, Glucose, 17); JJY (Multi-Analyte Controls, All Kinds (Assayed), 17).
Next steps
- See all 340 Boehringer Mannheim Corp. clearances with predicates and recalls
- Run predicate analysis for product code JJX, Boehringer Mannheim Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.